Wearable physiological monitoring system

ABSTRACT

A wearable respiration monitoring system having a transmitter coil that is adapted to generate and transmit multi-frequency AC magnetic fields, a receiver coil adapted to detect variable strengths in one of the AC magnetic fields and generate AC magnetic field strength signals representing anatomical displacements of a monitored subject, and at least one accelerometer that is configured to detect and monitor anatomical positions and movement of the subject, and generate and transmit accelerometer signals representing same. The wearable monitoring system further includes an electronics module that is adapted to receive the AC magnetic field strength signals and accelerometer signals, and determine at least one respiratory disorder as a function of the AC magnetic field strength signals and at least one anatomical position of the subject as a function of the accelerometer signals.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/419,358, filed on May 22, 2019, which is a continuation-in-part ofU.S. application Ser. No. 16/363,404, filed on Mar. 25, 2019, now U.S.Pat. No. 10,993,638, which is a continuation-in-part of U.S. applicationSer. No. 16/117,921, filed on Aug. 30, 2018, now U.S. Pat. No.10,314,517, which is a continuation of U.S. application Ser. No.15/133,497, filed on Apr. 20, 2016, now U.S. Pat. No. 10,064,570, whichis a continuation-in-part of U.S. application Ser. No. 13/854,280, filedon Apr. 1, 2013, now abandoned.

FIELD OF THE INVENTION

The present invention relates to systems and methods for monitoringphysiological characteristics of a subject. More particularly, thepresent invention relates to apparatus, systems and methods fordetermining a plurality of physiological characteristics; particularly,respiratory characteristics of a subject and respiratory disordersexhibited thereby, and anatomical positions and motions of the subject.

BACKGROUND OF THE INVENTION

It is well known in the art that approximately 10% of adults areaffected by a respiratory disorder. Most respiratory disorders aredeemed a serious risk factor because they can, and often will, have along-term effect on the cardiovascular system. Indeed, sympatheticmodulation has been found to be closely related to adverse heart ratevariability, e.g., cardiac arrhythmia.

The most common respiratory disorders that affect adults are sleepapneas and hypopnea.

As is well known in the art, sleep apnea is generally classified intothree types based on respiratory functions. The first type of apnea isobstructive sleep apnea (OSA), which occurs when the subject or patientstops breathing continuously due to an obstructed upper airway.

The second type of apnea is central sleep apnea (CEN), which occurs whenthe subject or patient stops breathing continuously due to the inabilityof the subject to correctly modulate respiration, i.e., the braintemporarily fails to transmit appropriate neurological signals to themuscles responsible for controlling breathing. Unlike obstructive sleepapnea, which can be thought of as a mechanical problem, central sleepapnea is more of a communication problem.

The third type of apnea is generally referred to as mixed apnea, whichis a combination of obstructive and central sleep apnea. Mixed apnea isgenerally characterized by a lack of respiratory effort without airexchange due to upper airway obstruction.

Hypopnea is a respiratory disorder that is characterized by overlyshallow breathing or an abnormally low respiration rate, i.e., adecreased amount of air movement into the lungs, which can, and oftenwill cause oxygen levels in the blood to drop.

As is also well known in the art, various abnormal seminal respiratoryparameters and/or characteristics, such as breathing frequency (e.g.,breaths per minute), tidal volume (V_(T)), inspiration volume,expiration volume, respiratory minute ventilation (e.g., inspirationvolume per minute or expiration volume per minute) and/or peakexpiratory flow rate, and physiological parameters and/orcharacteristics, such as oxyhemoglobin saturation and oxygendesaturation index, are indicative of a sleep apnea and/or hypopnea.

Various systems and methods have thus been developed to detect one ormore respiratory parameters and determine a respiratory disorder, suchas sleep apnea, therefrom. Most of the systems and methods are based onanatomical displacements and the relationships thereof to one or more ofthe above referenced respiratory parameters and characteristics, e.g.,breathing frequency, V_(T) and inspiration volume.

Illustrative are the systems and methods for determining respiratoryparameters disclosed in U.S. Pat. Nos. 8,790,273 and 8,790,274(hereinafter “McCool patents”). The systems disclosed in the referencedMcCool patents generally comprise at least two tuned pairs ofelectromagnetic (EM) coils (also referred to herein as “magnetometers”),where each pair of EM coils comprise a single-channel transmitter EMcoil that is adapted to transmit a single, specific high-frequency ACelectromagnetic field (i.e., transducer) and an EM coil (i.e., receiver)that is adapted to receive the AC electromagnetic field transmitted bythe transmitter EM coil.

The transmitter EM coil(s) of the McCool systems are positioned on thefront of a subject and the receiver EM coils are positioned on the backof the subject.

The systems disclosed in the McCool patents are configured to determineat least one respiratory parameter or characteristic; particularly,tidal volume (V_(T)) as a function of a plurality of anatomicaldistances, e.g., rib cage-anteroposterior distance andabdomen-anteroposterior distance, which are detected by the tuned pairsof EM coils, and a plurality of predetermined volume-motioncoefficients.

A major drawback and disadvantage associated with the McCool systems andassociated methods is the use of single-channel transmitter EM coilsthat (i) are limited to one (1) specific AC electromagnetic fieldfrequency and (ii) are susceptible to interference from extraneouselectromagnetic fields that negatively impact the voltage output of theEM coils and, hence, the consistency of the AC electromagnetic fieldfrequency.

A further drawback and disadvantage associated with the McCool systemsis that the McCool systems and associated methods are dependent on theuse of complex algorithms, which can, and often will, fail toquantitatively account for physiological differences between individualsubjects. As a result, the McCool systems are incapable of consistentlyproviding accurate determinations of seminal physiological parametersand/or characteristics, such as tidal volume (V_(T)) and minuteventilation (V-dot).

Another drawback and disadvantage associated with the McCool systems isthe extensive amount of cumbersome wiring that is required for theMcCool systems to operate.

Further systems and methods for determining respiratory parameters andrespiratory disorders associated therewith are disclosed in Applicant'sissued U.S. Pat. No. 10,064,570, and U.S. application Ser. No.16/117,921, now U.S. Pat. No. 10,314,517.

In contrast to the McCool systems, the systems disclosed in U.S. Pat.Nos. 10,064,570 and 10,314,517 comprise at least one permanent magnetcoupled with at least one magnetometer that is configured to receive theAC electromagnetic field generated by the permanent magnet. Themagnetometer is positioned on the front of a subject proximate thexyphoid process and the permanent magnet is positioned on the back ofthe subject proximate the spine and across from the xyphoid process ofthe subject.

The magnetometer of the above noted systems is adapted to detectstrength variations in the AC magnetic field emitted by the permanentmagnet, which reflect displacements, i.e., change in distance, by andbetween the magnetometer and permanent magnet and, hence, the axialdisplacements of the chest wall of the subject. The systems are thenprogrammed and configured to determine at least one respiratoryparameter of the subject as a function of the axial displacements of thesubject's chest wall.

A seminal advantage of the systems disclosed in U.S. Pat. Nos.10,064,570 and 10,314,517 comprises the use of a permanent rare earthmagnet that is capable of generating an AC magnetic field with asubstantially higher degree of magnetic field strength per unit masscompared to conventional magnetic field transducers.

Further advantages provided by the permanent rare earth magnet are thatthe permanent magnet is capable of providing an AC magnetic field with(i) a greater degree of magnetic field stability over time compared toconventional magnetic field transducers and (ii) that is minimallyimpacted by interference from extraneous electromagnetic fields comparedto conventional magnetic field transducers. The systems disclosed inU.S. Pat. Nos. 10,064,570 and 10,314,517 are thus capable of measuringmultiple respiratory parameters associated with a user or wearer with ahigh degree of accuracy, while minimizing inference from externalsources, such as electromagnetic radiation.

Further, since permanent rare earth magnets do not require an externalpower source or control module to generate an AC magnetic field, thesystems disclosed in U.S. Pat. Nos. 10,064,570 and 10,314,517 requiresubstantially less wiring and electrical power to operate compared toconventional systems, such as the systems disclosed by McCool.

Although the systems disclosed in U.S. Pat. Nos. 10,064,570 and10,314,517 can be readily employed to accurately determine multiplerespiratory parameters in real time and determine respiratory disorders;particularly, apneas and hypopnea therefrom, it is desirable to providean improved system based thereon with enhanced respiratory andphysiological parameter detection accuracy and, thereby, respiratorydisorder determination.

It is also well known in the art that the anatomical position of asubject during sleep can, and in many instances will, induce an adverseaction by the subject, e.g., gastrointestinal regurgitation, orexasperate an existing condition of the subject, e.g., sleep apnea.

At present there are few, if any, apparatus and/or systems availablethat are configured to accurately monitor anatomical positions andmovements of a subject during sleep.

There is thus a need to provide improved physiological monitoringsystems that accurately detect and measure respiratory parameters and/orcharacteristics in real time based on anatomical displacements of amonitored subject.

There is also a need to provide apparatus and systems that are capableof accurately detecting and monitoring anatomical positions andmovements of a subject during sleep.

It is therefore an object of the present invention to provide a wearablephysiological monitoring system that accurately detects and measuresrespiratory parameters and/or characteristics in real time based onanatomical displacements of a monitored subject.

It is another object of the present invention to provide a wearablephysiological monitoring system that accurately detects and measuresrespiratory and physiological parameters and characteristics in realtime based on anatomical displacements of a monitored subject.

It is another object of the present invention to provide a wearablephysiological monitoring system that accurately determines anatomicalpositions of a subject.

It is another object of the present invention to provide improvedmethods for determining a respiratory disorder based on detectedrespiratory and/or physiological parameters and/or characteristics.

It is another object of the present invention to provide improvedmethods for determining sleep apnea and/or hypopnea based on detectedabnormal respiratory and/or physiological parameters and/orcharacteristics.

SUMMARY OF THE INVENTION

The present invention is directed to wearable physiological monitoringsystems and improved methods for determining (i) respiratory and/orsleep disorders based on measured anatomical displacements and measuredphysiological parameters and/or characteristics, and (ii) anatomicalpositions and movement of a subject.

In a preferred embodiment of the invention, the wearable physiologicalmonitoring systems comprise a wearable garment that is configured tocover at least the chest region and upper back of a subject (or user).

In a preferred embodiment of the invention, the wearable physiologicalmonitoring systems comprise a respiratory parameter monitoringsub-system, an electronics, i.e., control-processing, module, andintegral signal transmission means associated therewith.

In some embodiments of the invention, the wearable physiologicalmonitoring systems further comprise a physiological parameter monitoringsub-system.

In some embodiments of the invention, the respiratory parametermonitoring sub-system comprises at least one transmitter coil andmultiple receiver coils.

In a preferred embodiment of the invention, the respiratory parametermonitoring sub-system comprises at least one transmitter coil and atleast one receiver coil.

In some embodiments of the invention, the physiological parametermonitoring sub-system further comprises an accelerometer that isconfigured and positioned to establish at least one anatomical positionof the subject and monitor physical movement of the subject.

In a preferred embodiment of the invention, the electronics modulecomprises a multi-channel module that is programmed and configured(i.e., comprises programs, parameters, instructions and at least onealgorithm) to control the physiological monitoring systems.

In some embodiments of the invention, the electronics module ispreferably programmed and configured to (i) receive AC magnetic fieldstrength signals that are generated and transmitted by the receivercoils, (ii) identify the frequency of each of the associated AC magneticfield strength signals, (iii) determine the identity of the receivercoil based on the frequency of the AC magnetic field strength signals,(iv) determine at least one respiratory parameter, more preferably, aplurality of respiratory parameters associated with the monitoredsubject as a function of the AC magnetic field strength signals, (v)determine at least one respiratory parameter value as a function of theAC magnetic field strength signals, and (vi) determine at least onerespiratory disorder as a function of the determined respiratoryparameter and determined value thereof.

In some embodiments of the invention, the electronics module is furtherprogrammed and configured to (i) receive at least one respiratoryparameter signal representing a pre-measured baseline respiratoryparameter value, and (ii) determine at least one respiratory disorder asa function of the pre-measured baseline respiratory parameter value andthe respiratory parameter and value thereof determined as a function ofthe AC magnetic field strength signals.

In some embodiments, the electronics module is further programmed andconfigured to receive and process physiological parameter signalsrepresenting physiological parameter values of a subject that aregenerated and transmitted by the physiological parameter monitoringsub-system, i.e., a physiological parameter sensor thereof.

In some embodiments of the invention, the electronics module ispreferably programmed and configured to (i) receive AC magnetic fieldstrength signals that are transmitted by the receiver coils andphysiological parameter signal(s) transmitted by a physiologicalparameter sensor, (ii) identify the frequency of each of the AC magneticfield strength signals, (iii) determine the identity of the receivercoil based on the frequency of the AC magnetic field strength signals,(iv) determine at least one respiratory parameter, more preferably, aplurality of respiratory parameters associated with the monitoredsubject as a function of the AC magnetic field strength signals, (v)determine at least one respiratory parameter value as a function of theAC magnetic field strength signals, and (vi) determine at least onerespiratory disorder as a function of the physiological parameter value,and the respiratory parameter and value thereof determined as a functionof the AC magnetic field strength signals.

In some embodiments, the electronics module is further programmed andconfigured to (i) receive accelerometer signals representing theanatomical position and movement data of the monitored subject that aregenerated and transmitted by an accelerometer, and (ii) determine atleast one respiratory disorder as a function of the pre-measuredbaseline respiratory parameter value, physiological parameter value,accelerometer data, and the respiratory parameter and value thereofdetermined as a function of the AC magnetic field strength signals.

In some embodiments, the electronics module is further programmed andconfigured to determine at least one anatomical position of themonitored subject as a function of the accelerometer data.

In some embodiments of the invention, the electronics module is alsoprogrammed and configured to generate and transmit at least oneanatomical position warning signal as a function of (or in response to)the determined anatomical position and a pre-determined anatomicalposition of the subject, e.g., erect, semi-erect, left lateral recumbentlying, right lateral recumbent lying, supine or prone position.

In a preferred embodiment, the anatomical position warning signalinduces excitation or warning events that are configured to prompt asubject to transition to an alternative position that is less likely toexacerbate and/or trigger a symptom of an existing respiratory or sleepdisorder of the subject, e.g., obstructive sleep apnea orgastroesophageal reflux disease.

In some embodiments of the invention, the physiological monitoringsystems further comprise a vibration device that is configured toreceive the anatomical position warning signal and generate a vibrationat a pre-determined frequency in response to the anatomical positionwarning signal.

In some embodiments of the invention, the physiological monitoringsystems further comprise an integral audio device that is configured toreceive the anatomical position warning signal and generate an audiblesignal at a pre-determined amplitude in response to the anatomicalposition warning signal.

In some embodiments of the invention, the physiological monitoringsystems further comprise a remote audio device that is configured toreceive the anatomical position warning signal and generate an audiblesignal at a pre-determined amplitude in response to the anatomicalposition warning signal.

In some embodiments of the invention, the method for determining arespiratory disorder and anatomical position of the subject generallycomprises:

(i) providing a wearable physiological monitoring system of theinvention;

(ii) positioning the wearable physiological monitoring system on thesubject;

(iii) initiating the wearable physiological monitoring system, whereinAC magnetic fields are generated and transmitted by the transmittercoil, the AC magnetic fields comprising predetermined frequencies;

(iv) detecting and measuring strengths in an AC magnetic field with areceiver coil;

(v) generating AC magnetic field strength signals representing themeasured AC magnetic field strengths with the receiver coil;

(vi) measuring accelerometer data with the system accelerometer andgenerating accelerometer signals representing the accelerometer data;

(vii) transmitting the AC magnetic field strength signals and theaccelerometer signals to the electronics module;

(viii) determining at least one anatomical displacement of the subjectas a function of the AC magnetic field strength signals;

(ix) determining at least one respiratory parameter of the subject as afunction of the determined anatomical displacement;

(x) determining a respiratory parameter value as a function of the ACmagnetic field strength signals;

(xi) determining at least one respiratory disorder as a function of thedetermined respiratory parameter and value thereof; and

(xii) determining at least one anatomical position of the subject as afunction of the accelerometer signals.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features and advantages will become apparent from the followingand more particular description of the preferred embodiments of theinvention, as illustrated in the accompanying drawings, and in whichlike referenced characters generally refer to the same parts or elementsthroughout the views, and in which:

FIG. 1 is a schematic illustration of one embodiment of a physiologicalmonitoring system, in accordance with the invention;

FIG. 2 is a schematic illustration of another embodiment of aphysiological monitoring system, in accordance with the invention;

FIG. 3 is a schematic illustration of yet another embodiment of aphysiological monitoring system, in accordance with the invention;

FIG. 4 is a perspective view of one embodiment of a wearablephysiological monitoring system positioned on a subject showing theposition of a transmitter coil proximate the xyphoid process and one (1)receiver coil proximate the umbilicus, in accordance with the invention;and

FIG. 5 is a side view of a subject, showing the position of atransmitter coil and three (3) receiver coils in a wearablephysiological monitoring system and, thereby, on the subject, inaccordance with one embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Before describing the present invention in detail, it is to beunderstood that this invention is not limited to particularlyexemplified apparatus, systems, structures or methods as such may, ofcourse, vary. Thus, although a number of apparatus, systems and methodssimilar or equivalent to those described herein can be used in thepractice of the present invention, the preferred apparatus, systems,structures and methods are described herein.

It is also to be understood that the terminology used herein is for thepurpose of describing particular embodiments of the invention only andis not intended to be limiting.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one having ordinaryskill in the art to which the invention pertains.

Further, all publications, patents and patent applications cited herein,whether supra or infra, are hereby incorporated by reference in theirentirety.

As used in this specification and the appended claims, the singularforms “a”, “an” and “the” include plural referents unless the contentclearly dictates otherwise. Thus, for example, reference to “an ACmagnetic field strength signal” includes two or more such signals andthe like.

Further, ranges can be expressed herein as from “about” or“approximately” one particular value, and/or to “about” or“approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about” or“approximately”, it will be understood that the particular value formsanother embodiment. It will be further understood that the endpoints ofeach of the ranges are significant both in relation to the otherendpoint, and independently of the other endpoint.

It is also understood that there are a number of values disclosedherein, and that each value is also herein disclosed as “about” or“approximately” that particular value in addition to the value itself.For example, if the value “10” is disclosed, then “approximately 10” isalso disclosed. It is also understood that when a value is disclosedthat “less than or equal to” the value, “greater than or equal to thevalue” and possible ranges between values are also disclosed, asappropriately understood by the skilled artisan. For example, if thevalue “10” is disclosed then “less than or equal to 10” as well as“greater than or equal to 10” is also disclosed.

Definitions

The terms “respiratory parameter”, “respiratory characteristic” and“respiration parameter” are used interchangeably herein, and mean andinclude a characteristic associated with the respiratory system andfunctioning thereof, including, without limitation, breathing frequency,tidal volume, inspiration volume, expiration volume, minute ventilation,inspiratory breathing time, expiratory breathing time, and flow rates(e.g., rates of change in the chest wall volume).

The terms “respiratory parameter”, “respiratory characteristic” and“respiration parameter” further mean and include parameters associatedwith ventilation mechanics from synchronous or asynchronous movements ofthe chest wall compartments.

The terms “physiological parameter” and “physiological characteristic”,as used herein, mean and include, without limitation, electricalactivity of the heart, electrical activity of other muscles, electricalactivity of the brain, pulse rate, blood pressure, blood oxygensaturation level, skin temperature, and core temperature.

The term “apnea,” as used herein, means and includes abnormalrespiration, as defined herein, of a subject, which is characterized byat least one respiratory parameter and/or physiological characteristic.

The term “apnea” thus means and includes abnormal respirationcharacterized by, without limitation, breathing frequency or respiratoryrate (f) (e.g., breaths per minute), tidal volume (V_(T)), inspirationvolume, expiration volume, respiratory minute ventilation (e.g.,inspiration volume per minute or expiration volume per minute) and/orpeak expiratory flow rate.

The term “apnea” thus means and includes the inability of a subject tocorrectly modulate respiration.

The term “apnea” also means and includes, without limitation, anobstruction of the subject's upper airway.

The term “apnea” further means and includes abnormal respirationcharacterized by, without limitation, a seminal blood oxygen parameterand/or blood oxygen characteristic including, without limitation,oxyhemoglobin saturation and oxygen desaturation index of a subject,e.g., oxyhemoglobin desaturation events per hour.

The term “apnea” thus means and includes, without limitation, areduction of a subject's oxyhemoglobin saturation level ≥5% of thesubject's average normal oxyhemoglobin saturation level.

The term “apnea” also means and includes, without limitation,counter-correlated contraction and expansion of the subject's thoracicand abdominal regions during at least one respiration cycle, i.e., theexpansion and contraction of the subject's thoracic and abdominalcavities are ˜180° out of phase.

The term “apnea” also means and includes central sleep apnea andobstructive sleep apnea.

The term “apnea” also means and includes complex sleep apnea or mixedsleep apnea, i.e., a combination of central and obstructive sleep apnea.

The term “apneic event,” as used herein, means and includes, withoutlimitation, a reduction of a subject's minute ventilation ≥30% of thesubject's average normal minute ventilation and/or a cessation in thesubject's breathing ≥10 seconds with an attendant reduction inoxyhemoglobin saturation.

The term “normal respiration” as used herein in connection with “apnea”means and includes, without limitation, a “normal” or “healthy”apnea/hypopnea index (AHI), i.e., an AHI score ≤5 apneic events per hourof a subject's sleep, wherein an apneic event is defined as (i) areduction of the subject's minute ventilation ≥30% of the subject'saverage normal minute ventilation and/or (ii) a cessation in thesubject's breathing ≥10 seconds with an attendant reduction inoxyhemoglobin saturation.

The term “abnormal respiration,” as used herein, means and includes,without limitation, cessation of a subject's breathing for a period ≥10seconds with an attendant reduction in oxyhemoglobin saturation (oroxygen saturation).

The term “abnormal respiration” further means and includes, withoutlimitation, a reduction of a subject's ventilation ≥30% of the subject'saverage normal ventilation.

The term “abnormal respiration” further means and includes, withoutlimitation, a reduction of a subject's minute ventilation (V-dot)≥30% ofthe subject's average normal minute ventilation.

The term “abnormal respiration” further means and includes, withoutlimitation, a “mild” apnea/hypopnea index (AHI) score in the range of5-15 apneic events per hour of a subject's sleep, wherein an apneicevent is defined as (i) a reduction of the subject's minute ventilation≥30% of the subject's average normal minute ventilation and/or (ii) acessation in the subject's breathing ≥10 seconds with an attendantreduction in oxyhemoglobin saturation.

The term “abnormal respiration” further means and includes, withoutlimitation, a “moderate” apnea/hypopnea index (AHI) score in the rangeof 15-30 events per hour of a subject's sleep, wherein an apneic eventis defined as (i) a reduction of the subject's minute ventilation ≥30%of the subject's average normal minute ventilation and/or (ii) acessation in the subject's breathing ≥10 seconds with an attendantreduction in oxyhemoglobin saturation.

The term “abnormal respiration” further means and includes, withoutlimitation, a “severe” apnea/hypopnea index (AHI) score ≥30 events perhour of a subject's sleep, wherein an apneic event is defined as (i) areduction of the subject's minute ventilation ≥30% of the subject'saverage normal minute ventilation and/or (ii) a cessation in thesubject's breathing for a period of at least 10 seconds with anattendant reduction in oxyhemoglobin saturation.

The term “abnormal respiration” further means and includes, withoutlimitation, a reduction of a subject's tidal volume (V_(T)) in the rangeof approximately 5-30% of the subject's average normal V_(T).

The terms “sleep disorder” and “respiratory disorder” are usedinterchangeably herein, and mean and include, without limitation, anapnea, sleep apnea, hypopnea, and abnormal respiration.

The term “resting position” as used herein in connection with “apnea”and “sleep apnea” means and includes minimal physical activity or motionand/or the absence of physical activity or motion, except motionassociated with normal breathing.

The terms “patient” and “subject” are used interchangeably herein, andmean and include warm blooded mammals, humans and primates; avians;domestic household or farm animals, such as cats, dogs, sheep, goats,cattle, horses and pigs; laboratory animals, such as mice, rats andguinea pigs; fish; reptiles; zoo and wild animals; and the like.

The terms “subject” and “patient” also mean and include a wearer or userof a respiratory parameter monitoring system or arespiratory-physiological parameter monitoring system of the invention.

The term “comprise” and variations of the term, such as “comprising” and“comprises,” means “including, but not limited to” and is not intendedto exclude, for example, other additives, components, integers or steps.

The following disclosure is provided to further explain in an enablingfashion the best modes of performing one or more embodiments of thepresent invention. The disclosure is further offered to enhance anunderstanding and appreciation for the inventive principles andadvantages thereof, rather than to limit in any manner the invention.The invention is defined solely by the appended claims including anyamendments made during the pendency of this application and allequivalents of those claims as issued.

Although the physiological monitoring systems and associated methods fordetermining respiratory and physiological parameters, and respiratorydisorders based thereon, and anatomical positions and movement of asubject are described herein in connection with determining respiratoryand physiological parameters, and respiratory and sleep disorders basedthereon, and anatomical positions and movement of a human subject, it isunderstood that the invention is not limited to such use. Indeed, thephysiological monitoring systems and associated methods can also bereadily employed to determine respiratory and physiological parameters,and respiratory and sleep disorders based thereon, and anatomicalpositions and movement of other mammalian bodies.

The physiological monitoring systems and associated methods of theinvention can also be employed in non-medical contexts, such asdetermining volumes and/or volume changes in extensible bladders usedfor containing liquids and/or gasses.

As indicated above, the present invention is directed to physiologicalmonitoring systems and improved methods employing same for determining(i) respiratory and sleep disorders of a subject based on measuredvariations in AC magnetic field strengths that are detected and measuredby a plurality of receiver coils as a function of the dimensionaldistances between each receiver coil and at least one magnetic fieldsource, i.e., a transmitter coil, and, hence, anatomical displacementsbased thereon, and, in some embodiments, physiological parameters and/orcharacteristics, and accelerometer data, and/or (ii) anatomicalpositions and movement of the subject.

As discussed in detail below, in a preferred embodiment, the monitoringsystems of the invention comprise a wearable garment that is configuredto cover at least the chest region and upper back of a wearer (or user).

In some embodiments of the invention, the monitoring systems comprise arespiratory parameter monitoring sub-system, electronics (i.e., controland processing) module and integral signal transmission means associatedtherewith.

In some embodiments, the monitoring systems similarly comprises arespiratory parameter monitoring sub-system, a physiological parametermonitoring sub-system, electronics module and integral signaltransmission means associated therewith.

In some embodiments of the invention, the respiratory parametermonitoring sub-system comprises at least one permanent magnet and atleast one magnetometer, such as disclosed in Applicant's Co-pending U.S.application Ser. No. 16/363,290, which is incorporated by referenceherein in its entirety.

In a preferred embodiment of the invention, the respiratory parametermonitoring sub-system comprises at least one transmitter coil andmultiple receiver coils, such as disclosed in Applicant's Co-pendingU.S. application Ser. No. 16/363,404, now U.S. Pat. No. 10,993,638,which is incorporated by reference herein in its entirety.

According to the invention, the respiratory parameter monitoringsub-system can comprise two (2) transmitter coils. As discussed indetail below, in such embodiments, one (1) transmitter coil ispositioned proximate the xyphoid process and another transmitter coil ispositioned proximate the umbilicus.

In a preferred embodiment of the invention, the respiratory parametermonitoring sub-system comprises three (3) receiver coils. According tothe invention, the respiratory parameter monitoring sub-system can,however, also comprise more or less than three (3) receiver coils.

In a preferred embodiment of the invention, the transmitter coil(s) areadapted to generate and transmit electromagnetic radiation, e.g., ACmagnetic fields, in three dimensions at multiple, non-harmonicfrequencies.

In a preferred embodiment, the non-harmonic frequencies are less than 10KHz.

In some embodiments, the non-harmonic frequencies are less than 5 KHz.

In some embodiments, the non-harmonic frequencies are in the range ofapproximately 5-10 KHz.

According to the invention, the transmitter coils can comprise anyapparatus or system that is adapted to generate and transmitelectromagnetic radiation at multiple frequencies.

In a preferred embodiment, the receiver coils are configured andpositioned to detect and measure the field strength in at least onefield dimension of at least one AC magnetic field at a definedfrequency, and generate at least one AC magnetic field strength signalrepresenting the field strengths in the detected field dimension of theAC magnetic field, and, thereby, anatomical displacements of themonitored subject.

More preferably, the receiver coils are configured and positioned todetect and measure the field strengths in multiple field dimensions ofat least one AC magnetic field at a defined frequency, and generate aplurality of AC magnetic field strength signals representing the fieldstrengths in the field dimensions of the AC magnetic field, and,thereby, anatomical displacements of the monitored subject.

According to the invention, the receiver coils can comprise anyapparatus or system that is configured to detect and measure fieldstrength in an AC magnetic field at a defined frequency, and generate atleast one AC magnetic field strength signal representing the measuredfield strength in the AC magnetic field, such as a magnetometer or Halleffect sensor.

In a preferred embodiment of the invention, the transmitter coil ispositioned at a first anatomical position proximate the subject'sxyphoid process and a first receiver coil is positioned at a secondanatomical position proximate the umbilicus, a second receiver coil ispositioned at a third anatomical position proximate the subject's spineopposite the transmitter coil, and a third receiver coil is positionedat a fourth anatomical position proximate the subject's spine oppositethe umbilicus.

According to the invention, other receiver placement configurations on asubject can be employed.

By way of example, in some embodiments of the invention, the transmittercoil is positioned proximate the subject's umbilicus and a firstreceiver coil is positioned proximate the subject's spine opposite thetransmitter coil, a second receiver coil is positioned proximate thesubject's xyphoid process, and a third receiver coil is positionedproximate the subject's spine opposite the xyphoid process.

In some embodiments of the invention, the transmitter coil is positionedproximate the subject's spine opposite the xyphoid process, and a firstreceiver coil is positioned proximate the xyphoid process, a secondreceiver coil is positioned proximate the subject's umbilicus, and athird receiver coil is positioned proximate the subject's spine oppositethe umbilicus.

In a preferred embodiment of the invention, the physiological parametermonitoring sub-system comprises at least one physiological parametersensor that is configured to (i) detect and measure a physiologicalparameter and, preferably, a value thereof, and (ii) generate aphysiological parameter signal representing the measured physiologicalparameter and, preferably, value thereof.

In some embodiments, the physiological parameter monitoring sensorcomprises a SpO₂ sensor.

In some embodiments, the physiological parameter monitoring sensorcomprises a body temperature sensor.

In some embodiments of the invention, the physiological parametermonitoring sub-system further comprises at least one accelerometer thatis configured and positioned to (i) detect anatomical positions of amonitored subject, and (ii) monitor physical movement of the subject.

In some embodiments, the accelerometer comprises a conventional three(3) axis accelerometer that is configured to detect at least oneaccelerometer parameter in an X, Y and/or Z direction.

According to the invention, the accelerometer is configured to generateand transmit at least one accelerometer signal representingaccelerometer data, including at least one accelerometer parameterrepresenting an anatomical position of a subject.

In a preferred embodiment, the accelerometer is configured andpositioned to generate a plurality of accelerometer signals that areprocessed and employed to determine at least one anatomical position ofthe subject, i.e., whether the subject is in an erect, semi-erect, leftlateral recumbent lying, right lateral recumbent lying, supine or proneposition.

As indicated above, in a preferred embodiment, the electronics modulecomprises a multi-channel module that is programmed and configured(i.e., comprises programs, parameters, instructions and at least onealgorithm) to control the monitoring systems of the invention.

In some embodiments of the invention, the electronics module is alsopreferably programmed and configured to (i) receive AC magnetic fieldstrength signals that are generated and transmitted by the receivercoils, (ii) identify the frequency of each of the associated AC magneticfield strength signals, (iii) determine the identity and, thereby,position of the receiver coil based on the frequency of the AC magneticfield strength signals, (iv) determine at least one respiratoryparameter, more preferably, a plurality of respiratory parametersassociated with the monitored subject as a function of the AC magneticfield strength signals, (v) determine at least one respiratory parametervalue as a function of the AC magnetic field strength signals, and (vi)determine at least one respiratory disorder as a function of thedetermined respiratory parameter and determined value thereof.

In some embodiments of the invention, the electronics module is furtherprogrammed and configured to (i) receive at least one respiratoryparameter signal representing a pre-measured baseline respiratoryparameter value, and (ii) determine at least one respiratory disorder asa function of the pre-measured baseline respiratory parameter value andthe respiratory parameter and value thereof determined as a function ofthe AC magnetic field strength signals.

In some embodiments of the invention, the electronics module is furtherprogrammed and configured to receive and process physiological parametersignals representing physiological parameter values of a subject thatare generated and transmitted by the physiological parameter monitoringsub-system, i.e., a physiological parameter sensor thereof.

Thus, in some embodiments, the electronics module is preferablyprogrammed and configured to (i) receive the AC magnetic field strengthsignals that are transmitted by the receiver coils and physiologicalparameter signal(s) transmitted by the physiological parameter sensor,(ii) identify the frequency of each of the AC magnetic field strengthsignals, (iii) determine the identity of the receiver coil based on thefrequency of the AC magnetic field strength signals, (iv) determine atleast one respiratory parameter, more preferably, a plurality ofrespiratory parameters associated with the monitored subject as afunction of the AC magnetic field strength signals, (v) determine atleast one respiratory parameter value as a function of the AC magneticfield strength signals, and (vi) determine at least one respiratorydisorder as a function of the physiological parameter value, and therespiratory parameter and value thereof determined as a function of theAC magnetic field strength signals.

In some embodiments, the electronics module is further programmed andconfigured to (i) receive accelerometer signals representing theanatomical position and movement data of the monitored subject that aregenerated and transmitted by an accelerometer, and (ii) determine atleast one respiratory disorder as a function of the pre-measuredbaseline respiratory parameter value, physiological parameter value,accelerometer data, and the respiratory parameter and value thereofdetermined as a function of the AC magnetic field strength signals.

In some embodiments of the invention, the electronics module is alsoprogrammed to determine a physiological parameter value as a function ofthe physiological parameter signal.

In some embodiments of the invention, the electronics module is alsoprogrammed and configured to generate and transmit at least onerespiratory disorder warning signal as a function of (or in response to)a pre-determined respiratory parameter threshold value and/orphysiological parameter threshold value.

In some embodiments, the electronics module is further programmed andconfigured to generate and transmit at least one anatomical positionwarning signal as a function of (or in response to) a determinedanatomical position and a pre-determined anatomical position of thesubject.

In a preferred embodiment of the invention, the monitoring systemsfurther comprise at least one excitation device, such as a vibration,audio or illuminating device, which generates or provides at least oneexcitation event, e.g., vibrations, in response to the respiratorydisorder warning signal and/or anatomical position warning signal.

In some embodiments of the invention, the monitoring systems thusfurther comprise a vibration device that is configured to receive therespiratory disorder warning signal and/or anatomical position warningsignal and generate vibrations at a pre-determined frequency orfrequencies in response to the respiratory disorder warning signaland/or anatomical position warning signal.

According to the invention, the vibration device can comprise variousconventional vibration devices, including, without limitation,piezoelectric vibrators, eccentric cam motors and electromagnetic (EM)vibrators.

In a preferred embodiment of the invention, the vibration device iscapable of generating vibrations with a frequency in the range ofapproximately 5-50 Hz.

In some embodiments, the vibration device is configured to generate aplurality of vibrations in a series of random or continuous pulses inintervals in the range of 1-30 seconds, more preferably, in intervals inthe range of 1-3 seconds.

In some embodiments of the invention, the monitoring systems furthercomprise a remote vibration device that is configured to receive therespiratory disorder warning signal and/or anatomical position warningsignal and generate the vibrations referenced above in response to therespiratory disorder warning signal and/or anatomical position warningsignal.

According to the invention, the remote vibration device can comprisevarious conventional vibration devices, including, without limitation,piezoelectric vibrators, eccentric cam motors and electromagnetic (EM)vibrators.

In a preferred embodiment of the invention, the remote vibration deviceis capable of vibrating at a frequency in the range of approximately5-50 cycles per second (Hz).

In some embodiments, the remote vibration device is similarly configuredto generate a plurality of vibrations in a series of random orcontinuous pulses in intervals in the range of 1-30 seconds, morepreferably, in intervals in the range of 1-3 seconds.

According to the invention, the monitoring systems can comprise aplurality of vibration devices that are configured to generate and,hence, transmit the same or different vibrations.

In some embodiments, the monitoring systems comprise a vibration devicethat is in communication with a subject's bed, such as a bed frame ormattress, or chair.

In some embodiments of the invention, the monitoring systems furthercomprise an integral audio device that is configured to receive therespiratory disorder warning signal and/or anatomical position warningsignal and produce an audible signal at a pre-determined amplitude inresponse to the respiratory disorder warning signal and/or anatomicalposition warning signal.

According to the invention, the integral audio device can comprisevarious conventional audio devices, including, without limitation,piezoelectric audio devices and electromagnetic audio devices, e.g.,speakers.

In a preferred embodiment of the invention, the audio device is capableof providing an audible signal with an amplitude in the range ofapproximately 70-90 dB.

In a preferred embodiment of the invention, the audio device is capableof generating acoustic signals with a frequency in the range ofapproximately 300-1200 Hz.

In some embodiments of the invention, the monitoring systems furthercomprise a remote audio device that is configured to receive therespiratory disorder warning signal and/or anatomical position warningsignal and produce an audible signal at a pre-determined amplitude inresponse to the respiratory disorder warning signal and/or anatomicalposition warning signal.

According to the invention, the remote audio device can similarlycomprise various conventional audio devices, including, withoutlimitation, piezoelectric audio devices and electromagnetic audiodevices, e.g., speakers.

In a preferred embodiment of the invention, the remote audio device iscapable of generating and transmitting an audible signal with anamplitude in the range of approximately 70-110 dB.

In a preferred embodiment of the invention, the remote audio device iscapable of generating and transmitting acoustic signals with frequenciesin the range of approximately 300-1200 Hz.

In some embodiments of the invention, the monitoring systems furthercomprise a remote illuminating device that is configured to receive therespiratory disorder warning signal and/or anatomical position warningsignal and produce a luminous signal in response to the respiratorydisorder warning signal and/or anatomical position warning signal.

According to the invention, the remote illuminating device can compriseany conventional device that is configured to generate light, such as alamp or any local light source.

In some embodiments of the invention, electronics module of themonitoring systems is also programmed and configured to transmit apre-programmed verbal notice or warning in response to the respiratorydisorder warning signal and/or anatomical position warning signal.

In some embodiments of the invention, the electronics module isprogrammed and configured to transmit a pre-programmed respiratorydisorder verbal warning to an emergency person or entity via a wirelesslink.

By way of example, in some embodiments, the electronics module isprogrammed to transmit the pre-programmed respiratory disorder verbalwarning to an emergency contact via a pre-programmed telephone number.

In some embodiments, the electronics module is programmed to transmitthe pre-programmed respiratory disorder verbal warning to an emergencyservice, e.g., police or fire department, via a pre-programmed emergencyservice telephone number, e.g., “911”.

In a preferred embodiment of the invention, the electronics module isprogrammed and configured to provide a plurality of respiratory disorderwarning signals and/or anatomical position warning signals that inducemulti-level excitation or warning events, i.e., vibrations of thevibration device at different frequencies, induced audible signals atdifferent amplitudes and verbal warnings to emergency contacts and/orservices, and combinations thereof, as a function of (or in response to)the respiratory disorder warning signals and/or anatomical positionwarning signals.

Referring now to Table I, there is shown one embodiment of asingle-level sleep disorder warning system of the invention. Asillustrated in Table I, the single-level respiratory disorder warningsystem preferably comprises at least one respiratory-physiologicalparameter threshold and at least one excitation event relating thereto.

TABLE 1 Respiratory- Alert Physiological Level Parameter ThresholdExcitation Event Level 1 “Mild” apnea/hypopnea A series of ~5-50 Hzvibrations index (AHI) score comprising at least 1-3 pulses in the rangeof 5- per second; preferably, sufficient 15 apneic events to fully wakea subject. The per hour of a vibrations transmitted until subject’ssleep. the subject wakes or turns off the vibration device.

Referring now to Table II, there is shown one embodiment of a two-levelrespiratory disorder warning system. As illustrated in Table II, thetwo-level respiratory disorder warning system, preferable comprises aplurality of respiratory-physiological parameter thresholds and at leastone excitation event relating thereto.

TABLE II Respiratory- Alert Physiological Level Parameter ThresholdExcitation Event Level 1 “Mild” A series of ~5-50 Hz vibrationsapnea/hypopnea comprising at least 1-3 pulses index (AHI) score persecond; preferably, sufficient in the range of 5- to fully wake asubject. The 15 apneic events vibrations transmitted until per hour of athe subject wakes or turns subject’s sleep. off the vibration device.Level 2 “Moderate” apnea/ A series of ~5-50 Hz vibrations hypopneacomprising at least 1 pulse index (AHI) score every two (2) seconds; inthe range of 15- preferably, sufficient 30 apneic events to fully wake asubject per hour of a and/or subject’s sleep. an audible signal of atleast 70 dB produced by an integral audio device and/or remote devicethat steadily increases amplitude to a maximum of 90 dB until thesubject wakes or turns off the vibration device and/or audible signal.

Referring now to Table III, there is shown one embodiment of athree-level respiratory disorder warning system. As illustrated in TableIII, the three-level sleep disorder warning system similarly preferablycomprises a plurality of respiratory-physiological parameter thresholdsand at least one excitation event relating thereto.

TABLE III Respiratory- Alert Physiological Level Parameter ThresholdExcitation Event Level 1 “Mild” apnea/hypopnea A series of ~5-50 Hzindex (AHI) score vibrations comprising in the range of 5- at least 1-3pulses per second; 15 apneic events preferably, sufficient to fully perhour of a wake a subject. The vibrations subject’s sleep. transmitteduntil the subject wakes or turns off the vibration device. Level 2“Moderate” A series of ~5-50 Hz vibrations apnea/hypopnea comprising atleast 1 pulse index (AHI) score every two (2) seconds; preferably, inthe range of sufficient to fully wake a subject 15-30 apneic eventsand/or per hour of a an audible signal of at least subject’s sleep. 70dB produced by an integral audio device and/or remote device thatsteadily increases amplitude to a maximum of 90 dB until the subjectwakes or turns off the vibration device and/or audible signal. Level 3“Severe” Transmittal of a verbal warning apnea/hypopnea to an emergencycontact index (AHI) and/or service, e.g., 911. score >30 apneic eventsper hour of a subject’s sleep.

As indicated above, in a preferred embodiment, the accelerometer isconfigured and positioned to (i) detect and monitor anatomical positionsand movements of the monitored subject, and (ii) generate a plurality ofaccelerometer signals that are processed and employed by the electronicsmodule to determine anatomical positions of the subject.

As also indicated above, in some embodiments, the electronics module isalso programmed and configured to generate and transmit at least oneanatomical position warning signal as a function of (or in response to)a determined anatomical position and a pre-determined anatomicalposition of the subject.

In a preferred embodiment of the invention, the pre-determined anddetermined anatomical positions include at least semi-erect, leftlateral recumbent, right lateral recumbent, supine and prone positions.

In a preferred embodiment, the anatomical position warning signalinduces excitation or warning events that are configured to prompt asubject to transition to an alternate anatomical position that is lesslikely to exacerbate and/or trigger a symptom of an existing respiratoryor sleep disorder of the subject, e.g., obstructive sleep apnea orgastroesophageal reflux disease.

Referring now to Table IV, there is shown one embodiment of asingle-level anatomical position warning system of the invention. Asillustrated in Table IV, the single-level anatomical position warningsystem preferably comprises at least one undesirable anatomical positionor condition and at least one excitation event relating thereto.

TABLE IV Anatomical Condition Excitation Event Subject A series of ~5-50Hz vibrations comprising sleeping in a at least 1-3 pulses per second;preferably, supine position. sufficient to prompt a subject totransition to a left lateral recumbent lying position. The vibrationstransmitted until the subject transitions to a left lateral recumbentlying position, wakes or turns off the vibration device.

Referring now to Table V, there is shown another embodiment of asingle-level anatomical position warning system of the invention. Theillustrated embodiment similarly comprises at least one undesirableanatomical position or condition and at least one excitation eventrelating thereto.

TABLE V Anatomical Condition Excitation Event Subject A series of ~5-50Hz vibrations comprising sleeping in a at least 1 pulse every two (2)seconds supine position. until the subject transitions to a left lateralrecumbent lying position, wakes or turns off the vibration device and/oran audible signal of at least 70 dB produced by an integral audio deviceand/or remote device that steadily increases amplitude to a maximum of90 dB until the subject transitions to a left lateral recumbent lyingposition, wakes or turns off the audible device.

Referring now to Table VI, there is shown another embodiment of asingle-level anatomical position warning system of the invention.

TABLE VI Anatomical Condition Excitation Event Subject A series of ~5-50Hz vibrations comprising sleeping in a at least 1 pulse every two (2)seconds prone position. until the subject transitions to a left lateralrecumbent lying position, wakes or turns off the vibration device and/oran audible signal of at least 70 dB produced by an integral audio deviceand/or remote device that steadily increases amplitude to a maximum of90 dB until the subject transitions to a left lateral recumbent lyingposition, wakes or turns off the audible device.

In a preferred embodiment of the invention, the anatomical positionwarning system is thus configured to train a subject to maintain ananatomical position during sleep that is less likely to exacerbateand/or trigger a symptom of an existing respiratory or sleep disorder ofthe subject.

In some embodiments of the invention, the anatomical position warningsystem is specifically configured to continuously train a subjectafflicted with obstructive sleep apnea to maintain a left or rightlateral recumbent lying anatomical position during sleep.

In some embodiments, the anatomical position warning system isspecifically configured to continuously train a subject afflicted withgastroesophageal reflux disease to maintain a left lateral recumbentlying anatomical position during sleep.

According to the invention, the anatomical position warning system canbe configured to train a subject to maintain an anatomical positionduring sleep that is less likely to exacerbate and/or trigger a symptomof any existing disorder or disease of a subject.

In some embodiments of the invention, the electronics module is furtherprogrammed and configured to continuously monitor the frequency of asubject's anatomical position transition events.

In some embodiments, electronics module is also programmed andconfigured to determine sleep parameters, e.g., total sleep time (TST),sleep efficiency (SE) and wake-after-sleep-onset (WASO), as a functionof acquired accelerometer data and determined respiratory parametervalues.

Thus, as set forth in detail in priority U.S. application Ser. No.16/363,404, now U.S. Pat. No. 10,993,638, in one embodiment of theinvention the monitoring systems generally comprise a wearable garmentthat is configured to be removably positioned on a subject, the subjectcomprising thoracic and abdominal regions, a spine, an umbilicus andxyphoid process of the sternum, wherein when the wearable garment ispositioned on a subject the wearable garment covers at least thethoracic and abdominal regions of the subject,

the wearable garment comprising a respiratory parameter monitoringsub-system and an electronics module in communication therewith,

the respiratory parameter monitoring sub-system comprising a transmittercoil and first, second and third receiver coils,

the transmitter coil and the first, second and third receiver coilsbeing positioned on the wearable garment, whereby, when the wearablegarment is positioned on the subject, the transmitter coil is positionedproximate the subject's xyphoid process, the first receiver coil ispositioned at a first anatomical region of the subject proximate thesubject's umbilicus at a first receiver coil distance from thetransmitter coil, the second receiver coil is positioned at a secondanatomical region of the subject proximate the subject's spine oppositethe subject's xyphoid process at a second receiver coil distance fromthe transmitter coil, the third receiver coil is positioned at a thirdanatomical region of the subject proximate the subject's spine oppositethe subject's umbilicus at a third receiver coil distance from thetransmitter coil,

the transmitter coil being adapted to generate a first alternatingcurrent (AC) magnetic field in first, second and third field dimensions,a second AC magnetic field in fourth, fifth and sixth field dimensions,and a third AC magnetic field in seventh, eighth and ninth fielddimensions,

the first, second and third field dimensions of the first AC magneticfield comprising a first field frequency, the fourth, fifth and sixthfield dimensions of the second AC magnetic field comprising a secondfield frequency, and the seventh, eighth and ninth field dimensions ofthe third AC magnetic field comprising a third field frequency,

the first field dimension of the first AC magnetic field comprising afirst variable strength as a function of a first distance of the firstreceiver coil from the transmitter coil, the second field dimension ofthe first AC magnetic field comprising a second variable strength as afunction of a second distance of the first receiver coil from thetransmitter coil, and the third field dimension of the first AC magneticfield dimension comprising a third variable strength as a function of athird distance of the first receiver coil from the transmitter coil,

the fourth field dimension of the second AC magnetic field comprising afourth variable field strength as a function of a fourth distance of thesecond receiver coil from the transmitter coil, the fifth fielddimension of the second AC magnetic field comprising a fifth variablefield strength as a function of a fifth distance of the second receivercoil from the transmitter coil, and the sixth field dimension of thesecond AC magnetic field comprising a sixth variable field strength as afunction of a sixth distance of the second receiver coil from thetransmitter coil,

the seventh field dimension of the third AC magnetic field comprising aseventh variable field strength as a function of a seventh distance ofthe third receiver coil from the transmitter coil, the eighth fielddimension of the third AC magnetic field comprising an eighth variablefield strength as a function of an eighth distance of the third receivercoil from the transmitter coil, and the ninth field dimension of thethird AC magnetic field comprising a ninth variable field strength as afunction of a ninth distance of the third receiver coil from thetransmitter coil,

the first receiver coil being configured to detect and measure thefirst, second and third variable field strengths in the first, secondand third field dimensions of the first AC magnetic field, the firstreceiver coil being further configured to generate a first AC magneticfield strength signal representing the first variable field strength inthe first field dimension of the first AC magnetic field, a second ACmagnetic field strength signal representing the second variable fieldstrength in the second field dimension of the first AC magnetic field,and a third AC magnetic field strength signal representing the thirdvariable field strength in the third field dimension of the first ACmagnetic field, and transmit the first, second and third AC magneticfield strength signals to the electronics module,

the second receiver coil being configured to detect and measure thefourth, fifth and sixth variable field strengths in the fourth, fifthand sixth field dimensions of the second AC magnetic field, the secondreceiver coil being further configured to generate a fourth AC magneticfield strength signal representing the fourth variable field strength inthe fourth field dimension of the second AC magnetic field, a fifth ACmagnetic field strength signal representing the fifth variable fieldstrength in the fifth field dimension of the second AC magnetic field,and a sixth AC magnetic field strength signal representing the sixthvariable field strength in the sixth field dimension of the second ACmagnetic field, and transmit the fourth, fifth and sixth AC magneticfield strength signals to the electronics module,

the third receiver coil being configured to detect and measure theseventh, eighth and ninth variable field strengths in the seventh,eighth and ninth field dimensions of the third AC magnetic field, thethird receiver coil being further configured to generate a seventh ACmagnetic field strength signal representing the seventh variable fieldstrength in the seventh field dimension of the third AC magnetic field,an eighth AC magnetic field strength signal representing the eighthvariable field strength in the eighth field dimension of the third ACmagnetic field, and a ninth AC magnetic field strength signalrepresenting the ninth variable field strength in the ninth fielddimension of the third AC magnetic field, and transmit the seventh,eighth and ninth AC magnetic field strength signals to the electronicsmodule,

the electronics module being adapted to receive the first, second andthird AC magnetic field strength signals transmitted by the firstreceiver coil, the fourth, fifth and sixth AC magnetic field strengthsignals transmitted by the second receiver coil and the seventh, eighthand ninth AC magnetic field strength signals transmitted by the thirdreceiver coil,

the electronics module comprising a processing system that is programmedand configured to determine at least one respiratory parameter of thesubject as a function of the first, second, third, fourth, fifth, sixth,seventh, eighth and ninth AC magnetic field strength signals,

the processing system being further programmed and configured todetermine a value of the at least one respiratory parameter of thesubject as a function of the first, second, third, fourth, fifth, sixth,seventh, eighth and ninth AC magnetic field strength signals,

the processing system being further programmed and configured todetermine a value of the at least one respiratory parameter of thesubject as a function of the first, second, third, fourth, fifth, sixth,seventh, eighth and ninth AC magnetic field strength signals,

the processing system being further programmed and configured todetermine at least one respiratory disorder of the subject as a functionof the determined at least one respiratory parameter and said determinedvalue thereof.

In some embodiments of the invention, wherein a baseline respiratoryparameter value is pre-measured, the processing system is furtherprogrammed and configured to determine at least one respiratory or sleepdisorder of the subject as a function of the pre-measured baselinerespiratory parameter value and the determined at least one respiratoryparameter and value thereof.

In a preferred embodiment of the invention, the transmitter coil and thefirst receiver coil are in a first axial alignment, the transmitter coiland the second receiver coil are in a second axial alignment and thetransmitter coil and the third receiver coil are in a third axialalignment.

As also set forth in detail in priority U.S. application Ser. No.16/363,404, in another embodiment of the invention the monitoringsystems similarly comprise a wearable garment that is configured to beremovably positioned on a subject, the subject comprising a spine, anumbilicus and xyphoid process of the sternum, wherein when the wearablegarment is positioned on a subject the wearable garment covers at leasta thoracic and abdominal region of the subject,

the wearable garment comprising a respiratory parameter monitoringsub-system, physiological parameter sub-system and an electronicsmodule,

the respiratory parameter monitoring sub-system comprising a transmittercoil and first, second and third receiver coils,

the physiological parameter sub-system comprising at least onephysiological parameter sensor,

the transmitter coil and the first, second and third receiver coilsbeing positioned on the wearable garment, whereby, when the wearablegarment is positioned on the subject, the transmitter coil is positionedproximate the subject's xyphoid process, the first receiver coil ispositioned at a first anatomical region of the subject proximate thesubject's umbilicus at a first receiver coil distance from thetransmitter coil, the second receiver coil is positioned at a secondanatomical region of the subject proximate the subject's spine oppositethe subject's xyphoid process at a second receiver coil distance fromthe transmitter coil, the third receiver coil is positioned at a thirdanatomical region of the subject proximate the subject's spine oppositethe subject's umbilicus at a third receiver coil distance from thetransmitter coil,

the transmitter coil being adapted to generate a first alternatingcurrent (AC) magnetic field in first, second and third field dimensions,a second AC magnetic field in fourth, fifth and sixth field dimensions,and a third AC magnetic field in seventh, eighth and ninth fielddimensions,

the first, second and third field dimensions of the first AC magneticfield comprising a first field frequency, the fourth, fifth and sixthfield dimensions of the second AC magnetic field comprising a secondfield frequency, and the seventh, eighth and ninth field dimensions ofthe third AC magnetic field comprising a third field frequency,

the first field dimension of the first AC magnetic field comprising afirst variable strength as a function of a first distance of the firstreceiver coil from the transmitter coil, the second field dimension ofthe first AC magnetic field comprising a second variable strength as afunction of a second distance of the first receiver coil from thetransmitter coil, and the third field dimension of the first AC magneticfield dimension comprising a third variable strength as a function of athird distance of the first receiver coil from the transmitter coil,

the fourth field dimension of the second AC magnetic field comprising afourth variable field strength as a function of a fourth distance of thesecond receiver coil from the transmitter coil, the fifth fielddimension of the second AC magnetic field comprising a fifth variablefield strength as a function of a fifth distance of the second receivercoil from the transmitter coil, and the sixth field dimension of thesecond AC magnetic field comprising a sixth variable field strength as afunction of a sixth distance of the second receiver coil from thetransmitter coil,

the seventh field dimension of the third AC magnetic field comprising aseventh variable field strength as a function of a seventh distance ofthe third receiver coil from the transmitter coil, the eighth fielddimension of the third AC magnetic field comprising an eighth variablefield strength as a function of an eighth distance of the third receivercoil from the transmitter coil, and the ninth field dimension of thethird AC magnetic field comprising a ninth variable field strength as afunction of a ninth distance of the third receiver coil from thetransmitter coil,

the first receiver coil being configured to detect and measure thefirst, second and third variable field strengths in the first, secondand third field dimensions of the first AC magnetic field, the firstreceiver coil being further configured to generate a first AC magneticfield strength signal representing the first variable field strength inthe first field dimension of the first AC magnetic field, a second ACmagnetic field strength signal representing the second variable fieldstrength in the second field dimension of the first AC magnetic field,and a third AC magnetic field strength signal representing the thirdvariable field strength in the third field dimension of the first ACmagnetic field, and transmit the first, second and third AC magneticfield strength signals to the electronics module,

the second receiver coil being configured to detect and measure thefourth, fifth and sixth variable field strengths in the fourth, fifthand sixth field dimensions of the second AC magnetic field, the secondreceiver coil being further configured to generate a fourth AC magneticfield strength signal representing the fourth variable field strength inthe fourth field dimension of the second AC magnetic field, a fifth ACmagnetic field strength signal representing the fifth variable fieldstrength in the fifth field dimension of the second AC magnetic field,and a sixth AC magnetic field strength signal representing the sixthvariable field strength in the sixth field dimension of the second ACmagnetic field, and transmit the fourth, fifth and sixth AC magneticfield strength signals to the electronics module,

the third receiver coil being configured to detect and measure theseventh, eighth and ninth variable field strengths in the seventh,eighth and ninth field dimensions of the third AC magnetic field, thethird receiver coil being further configured to generate a seventh ACmagnetic field strength signal representing the seventh variable fieldstrength in the seventh field dimension of the third AC magnetic field,an eighth AC magnetic field strength signal representing the eighthvariable field strength in the eighth field dimension of the third ACmagnetic field, and a ninth AC magnetic field strength signalrepresenting the ninth variable field strength in the ninth fielddimension of the third AC magnetic field, and transmit the seventh,eighth and ninth AC magnetic field strength signals to the electronicsmodule,

the electronics module being adapted to receive the first, second andthird AC magnetic field strength signals transmitted by the firstreceiver coil, the fourth, fifth and sixth AC magnetic field strengthsignals transmitted by the second receiver coil and the seventh, eighthand ninth AC magnetic field strength signals transmitted by the thirdreceiver coil,

the electronics module comprising a processing system that is programmedand configured to determine at least one respiratory parameter of thesubject as a function of the first, second, third, fourth, fifth, sixth,seventh, eighth and ninth AC magnetic field strength signals,

the processing system being further programmed and configured todetermine a value of the at least one respiratory parameter of thesubject as a function of the first, second, third, fourth, fifth, sixth,seventh, eighth and ninth AC magnetic field strength signals,

the processing system being further programmed and configured todetermine a value of the at least one respiratory parameter of thesubject as a function of the first, second, third, fourth, fifth, sixth,seventh, eighth and ninth AC magnetic field strength signals,

the processing system being further programmed and configured todetermine at least one respiratory disorder of the subject as a functionof the physiological parameter value, and the determined at least onerespiratory parameter and the determined value thereof.

In a preferred embodiment of the invention, the transmitter coil and thefirst receiver coil are similarly in a first axial alignment, thetransmitter coil and the second receiver coil are in a second axialalignment and the transmitter coil and the third receiver coil are in athird axial alignment.

In some embodiments of the invention, wherein a baseline respiratoryparameter value is pre-measured, the processing system is furtherprogrammed and configured to determine at least one respiratory disorderof the subject as a function of the pre-measured baseline respiratoryparameter value, physiological parameter value, and the determined atleast one respiratory parameter and value thereof.

As also set forth in priority U.S. application Ser. No. 16/363,404 anddiscussed in detail above, in some embodiments of the invention, thephysiological parameter sub-system of the monitoring systems of theinvention further comprise an accelerometer that is configured detectand monitor anatomical positions and physical movement of the subject,and generate and transmit accelerometer signals representing same,including accelerometer data representing at least one anatomicalposition of the subject.

Thus, in some embodiments of the invention, the processing system isfurther programmed and configured to determine at least one respiratorydisorder of the subject as a function of the pre-measured baselinerespiratory parameter value, physiological parameter value,accelerometer data, and the determined at least one respiratoryparameter and value thereof.

In some embodiments of the invention, the processing system is alsoprogrammed and configured to determine at least one anatomical positionof the subject as a function of the accelerometer signals and, hence,accelerometer data embodied in same.

In some embodiments of the invention, the processing system is furtherprogrammed and configured to selectively determine at least onerespiratory disorder of the subject as a function of the physiologicalparameter value and the determined at least one respiratory parameterand value thereof or at least one anatomical position of the subject asa function of the accelerometer signals and, hence, accelerometer dataembodied in same.

As also set forth in priority U.S. application Ser. No. 16/363,404, insome embodiments of the invention, the method for determining arespiratory disorder with a monitoring system of the invention generallycomprises:

(i) providing a wearable monitoring system comprising a respiratoryparameter monitoring sub-system, physiological parameter monitoringsub-system and electronics control-processing module, the respiratoryparameter monitoring sub-system comprising one transmitter coil andthree, i.e., first, second and third, receiver coils, the physiologicalparameter monitoring sub-system comprising at least one physiologicalparameter monitoring sensor;

(ii) positioning the monitoring system on the subject, wherein thetransmitter coil is positioned proximate the subject's xyphoid processand the first receiver coil is positioned proximate the umbilicus, thesecond receiver coil is positioned proximate the subject's spineopposite the transmitter coil, and the third receiver coil is positionedproximate the subject's spine opposite the umbilicus, and wherein thephysiological parameter monitoring sensor is positioned proximate atarget physical structure, e.g., the subject's skin;

(iii) initiating the monitoring system, wherein AC magnetic fields aregenerated and transmitted by the transmitter coil, the AC magneticfields comprising predetermined frequencies;

(iv) generating and transmitting AC magnetic fields with the transmittercoil, the AC magnetic fields comprising predetermined frequencies;

(v) detecting and measuring strengths in the AC magnetic fields with thereceiver coils;

(vi) generating AC magnetic field strength signals representing themeasured AC magnetic field strengths with the receiver coils;

(vii) measuring at least one physiological parameter and value thereofwith the physiological parameter monitoring sub-system and generating aphysiological parameter signal representing the physiological parameterand value thereof;

(viii) transmitting the AC magnetic field strength signals and thephysiological signal to the electronics module;

(ix) determining at least one anatomical displacement of the subject asa function of the AC magnetic field strength signals with theelectronics module;

(x) determining at least one respiratory parameter of the subject as afunction of the determined anatomical displacement with the electronicsmodule;

(xi) determining a respiratory parameter value as a function of the ACmagnetic field strength signals with the electronics module; and

(xii) determining at least one respiratory disorder as a function of thephysiological parameter value, and determined respiratory parameter andvalue thereof with the electronics module.

In some embodiments of the invention, the method for determining arespiratory disorder and anatomical position of a subject generallycomprises:

(i) providing a wearable monitoring system comprising a respiratoryparameter monitoring sub-system and electronics control-processingmodule, the respiratory parameter monitoring sub-system comprising onetransmitter coil and first, second and third, receiver coils, therespiratory parameter monitoring sub-system comprising at least onephysiological parameter monitoring sensor and an accelerometer;

(ii) positioning the monitoring system on the subject, wherein thetransmitter coil is positioned proximate the subject's xyphoid processand the first receiver coil is positioned proximate the umbilicus, thesecond receiver coil is positioned proximate the subject's spineopposite the transmitter coil, and the third receiver coil is positionedproximate the subject's spine opposite the umbilicus, and wherein thephysiological parameter monitoring sensor is positioned proximate atarget physical structure, e.g., the subject's skin;

(iii) initiating the monitoring system, wherein AC magnetic fields aregenerated and transmitted by the transmitter coil, the AC magneticfields comprising predetermined frequencies;

(iv) detecting and measuring strengths in the AC magnetic fields withthe receiver coils;

(v) generating AC magnetic field strength signals representing themeasured AC magnetic field strengths with the receiver coils;

(vi) acquiring accelerometer data with the accelerometer and generatingaccelerometer signals representing the accelerometer data, theaccelerometer data including accelerometer parameters representinganatomical positions and movement of the subject;

(vii) transmitting the AC magnetic field strength signals and theaccelerometer signals to the electronics module;

(viii) determining at least one anatomical displacement of the subjectas a function of the AC magnetic field strength signals with theelectronics module;

(ix) determining at least one respiratory parameter of the subject as afunction of the determined anatomical displacement with the electronicsmodule;

(x) determining a respiratory parameter value as a function of the ACmagnetic field strength signals with the electronics module;

(xi) determining at least one respiratory disorder as a function of theacquired baseline accelerometer data and the determined respiratoryparameter and value thereof with the electronics module; and

(xii) determining at least one anatomical position of the subject as afunction of the accelerometer signals with the electronics module.

Referring now to FIG. 1 , there is shown a schematic illustration of oneembodiment of a monitoring system of the invention. As illustrated inFIG. 1 , the monitoring system 100 preferably comprises a respiratoryparameter monitoring sub-system 2 of the invention, an electronicsmodule 6 and signal transmission conductors 8.

As also illustrated in FIG. 1 , the respiratory parameter monitoringsub-system 2 comprises a transmitter coil 15, first, second and thirdreceiver coils 16 a, 16 b, 16 c.

As further illustrated in FIG. 1 , the respiratory parameter monitoringsystem 100 further comprises a power source 10. According to theinvention, the power source 10 can comprise any device or systemconfigured to provide (or generate) electrical energy, such as abattery.

In a preferred embodiment of the invention, the monitoring system 100preferably comprises a wearable garment that is configured to cover atleast a portion of the torso of a subject, i.e., the thoracic andabdominal regions.

Referring now to FIG. 2 , there is shown a schematic illustration ofanother embodiment of a monitoring system of the invention. Asillustrated in FIG. 2 , the monitoring system 102 similarly preferablycomprises a respiratory parameter monitoring sub-system 2, anelectronics module 6 and signal transmission conductors 8.

As also illustrated in FIG. 2 , the respiratory parameter monitoringsub-system 2 similarly comprises a transmitter coil 15, first, secondand third receiver coils 16 a, 16 b, 16 c.

As further illustrated in FIG. 2 , the monitoring system 102 furthercomprises a physiological parameter monitoring sub-system 4 a of theinvention.

In a preferred embodiment of the invention, the monitoring system 102similarly preferably comprises a wearable garment that is configured tocover at least a portion of the torso of a subject, i.e., the thoracicand abdominal regions.

As indicated above, in a preferred embodiment of the invention,transmitter coil 15 is adapted to generate and transmit electromagneticradiation, e.g., AC magnetic fields, in multiple fields, i.e., athree-dimensional field, at multiple, non-harmonic frequencies.

As indicated above, preferably the non-harmonic frequencies are lessthan 10 KHz.

As also indicated above, in a preferred embodiment, the first, secondand third receiver coils 16 a, 16 b and 16 c are configured andpositioned to detect and measure field strength in at least one of thefield dimensions of the AC magnetic fields and generate AC magneticfield strength signals representing the field strengths in the ACmagnetic fields, and, thereby, anatomical displacements of the monitoredsubject.

In at least one embodiment, the first and second transmitter coils areconfigured and positioned on a subject, wherein the polarities of the ACmagnetic fields generated by the transmitter coils that are orientedperpendicular to each other, i.e., at a 90° angle relative to eachother, wherein a net vector field, comprising at least X and Y vectors(or directions), of the AC magnetic fields is provided.

In a preferred embodiment of the invention, at least one receiver coilis configured to detect at least one AC magnetic field vector in theX-direction and at least one receiver coil is configured to detect atleast one AC magnetic field vector in the Y-direction.

In the noted embodiments of the invention, wherein two (2) transmittercoils are employed, when the AC magnetic field vectors in the X and Ydirections are detected by the receiver coils, an angle between the Xand Y AC magnetic field vectors and a net AC magnetic field vector basedthereon is determined by the processing system of an electronics module.The angle between the X and Y AC magnetic field vectors and the net ACmagnetic field vector are then used to determine at least one net ACmagnetic field strength vector.

As indicated above and illustrated in FIG. 2 , in a preferred embodimentof the invention, the physiological parameter monitoring sub-system 4 aof the respiratory-physiological parameter monitoring system 102comprises at least one physiological parameter monitoring sensor.

As further illustrated in FIG. 2 , in some embodiments, thephysiological parameter monitoring sensor 4 a preferably comprises aSpO₂ sensor 18.

In some embodiments of the invention, the physiological parametermonitoring sub-system 4 a comprises at least one additionalphysiological parameter monitoring sensor, such as a temperature sensor(shown in phantom and denoted 19).

In a preferred embodiment of the invention, the electronics module 6preferably comprises a processing system or module, which is programmedand configured to control the respiratory-physiological parametermonitoring system 2 and the function thereof, and a data transmissionmodule, which is programmed and configured to control the transmissionand receipt of signals to and from the respiratory parameter monitoringsub-system 2 and physiological parameter monitoring sub-system 4 a.

As indicated above, in a preferred embodiment of the invention, theprocessing system comprises at least one algorithm that is programmedand configured to isolate and process the AC magnetic field strengthsignals and determine at least one respiratory parameter (orcharacteristic) of a subject as a function of the AC magnetic fieldstrength signals.

As set forth in priority U.S. application Ser. No. 16/363,404, theprocessing system algorithm for determining a respiratory parameter (orcharacteristic) as a function of AC magnetic field strength signals cancomprise various conventional algorithms, including, without limitation,a conventional and/or modified multiple-degree of freedom algorithm,including, without limitation, a two (2) degree of freedom algorithm andthree (3) degree of freedom algorithm, a spectral density estimationalgorithm using non-parametric methods, including, without limitation,singular spectrum analysis, short-time Fourier transform, cross-powermethod, transfer function estimate and magnitude squared coherence, andfrequency domain algorithm, including, without limitation, a Fourierseries algorithm, Fourier transform algorithm, Laplace transformalgorithm, Z transform algorithm and wavelet transform algorithm.

As also set forth in priority U.S. application Ser. No. 16/363,404, theprocessing system is also preferably programmed and configured togenerate and continuously update at least one diagnostic data set.Preferably, the diagnostic data set correlates at least one array ofmeasured or determined respiratory parameters with at least one array ofmeasured or determined anatomical displacement parameters of a subject.

Referring now to Table VII, there is shown an illustration of oneembodiment of a diagnostic data set for a subject. As illustrated inTable VII, the diagnostic data set preferably comprises at least anarray of measured or determined minute ventilation values and anatomicaldisplacements measured at defined points on a subject during monitoringwith a respiratory parameter or respiratory-physiological parametermonitoring system of the invention.

TABLE VII Subject #1 Minute Anatomical Point Ventilation DisplacementNo. (V-dot) (V_(M1), V_(M2)) 0 V-dot₀ (V_(M1), V_(M2))₀ 1 V-dot₁(V_(M1), V_(M2))₁ 2 V-dot₂ (V_(M1), V_(M2))₂ 3 V-dot₃ (V_(M1), V_(M2))₃4 V-dot₄ (V_(M1), V_(M2))₄ 5 V-dot₅ (V_(M1), V_(M2))₅ 6 V-dot₆ (V_(M1),V_(M2))₆

According to the invention, the diagnostic data set shown in Table VIIcan be graphically presented, i.e., minute ventilation on the y-axis andanatomical displacement on the x-axis, and linearly interpolated usingconventional equations, such as Eq. 1 shown below.

$y = {y_{1} + {\left( {x - x_{1}} \right)\frac{y_{2} - y_{1}}{x_{2} - x_{1}}}}$

In a preferred embodiment, the processing system is programmed andconfigured to linearly interpolate a diagnostic data set, such as thediagnostic data set shown in Table VII, and determine the presence of atleast one apneic event exhibited by a subject over a predeterminedperiod of time and, thereby, a sleep disorder.

According to the invention, the diagnostic data set can be interpolatedusing any applicable methods and/or equations. In some embodiments,processing system is programmed and configured to interpolate adiagnostic data set using quadratic polynomial interpolation anddetermine the presence of at least one apneic event exhibited by asubject over a predetermined period of time and, thereby, a sleepdisorder.

In some embodiments of the invention, a subject's tidal volume (V_(T))and respiratory rate (f) are determined via spirometry. Minuteventilation (V-dot) can then be determined using the equation shownbelow.

$\begin{matrix}{{V‐{dot}} = {V_{T} \times f}} & {{Eq}.2}\end{matrix}$

In a preferred embodiment of the invention, the processing system isfurther programmed to differentiate between indicia of a sleep disorder,i.e., respiratory and/or physiological parameters indicative of a sleepdisorder, and extraneous respiratory events, such as coughing, hiccups,sneezing, etc. by, for example, comparing the pre-measured baselinerespiratory and pre-measured baseline physiological parameters of thesubject in a resting position to pre-determined respiratory andphysiological parameter threshold values reflecting a respiratorydisorder.

In a preferred embodiment of the invention, the processing system isfurther programmed to determine a type of sleep apnea, i.e., obstructivesleep apnea, central sleep apnea and complex sleep apnea, based ondetected anatomical displacements of a monitored subject.

In some embodiments, the processing system determines the type of sleepapnea of a subject based on the correlation or synchrony between theexpansion and contraction of the subject's thoracic and abdominalregions (or chest wall and abdominal wall) during at least onerespiratory cycle.

As is well established, when a subject is afflicted with obstructivesleep apnea, the subject will exhibit a counter-correlated expansion andcontraction of the thoracic and abdominal regions, i.e., the expansionand contraction of the thoracic and abdominal regions are ˜180° out ofphase, during at least one respiratory cycle.

As is also well established, when a subject is afflicted with centralsleep apnea, the subject will exhibit a complete absence of thoracic andabdominal region expansion and contraction.

Thus, according to the invention, when the AC magnetic field strengthsignals reflect counter-correlated expansion and contraction of asubject's thoracic and abdominal regions during at least one respiratorycycle, a determination of obstructive sleep apnea is provided.

When the AC magnetic field strength signals reflect the absence ofthoracic and abdominal region expansion and contraction, a determinationof central sleep apnea is provided.

In a preferred embodiment of the invention, the electronics module 6further comprises a data transmission sub-system that is programmed andconfigured to control the transmission of signals from the respiratoryparameter monitoring sub-system 2 and physiological parameter monitoringsub-system 4 a.

In some embodiments, the data transmission sub-system is also preferablyprogrammed and configured to transmit the respiratory parameter signalsto a remote signal receiving device, e.g., a base module or a hand-heldelectronic device, such as a smart phone, tablet, computer, etc. In someembodiments, the remote signal receiving device is programmed andconfigured to display received and/or processed signals, e.g.,respiration parameter signals, physiological parameter signals andaccelerometer data received from the electronics module 6.

As further illustrated in FIG. 2 , the respiratory-physiologicalparameter monitoring system 102 also similarly includes signaltransmission conductors 8, which facilitate connection and, thereby,signal communication by and between the respiratory parameter monitoringsub-system 2, physiological parameter monitoring sub-system 4 a, andelectronics module 6.

Referring now to FIG. 3 , there is shown a schematic illustration ofanother embodiment of a respiratory-physiological parameter monitoringsystem of the invention. As illustrated in FIG. 3 , therespiratory-physiological parameter monitoring system 104 similarlypreferably comprises a respiratory parameter monitoring sub-system 2, aphysiological parameter monitoring sub-system comprising at least onephysiological parameter monitoring sensor, electronics module 6, signaltransmission conductors 8, and a power source 10, such as embodied inthe respiratory-physiological parameter monitoring system 102 describedabove.

As further illustrated in FIG. 3 , in this embodiment, the physiologicalparameter monitoring sub-system (now denoted “4 b”) further comprises anaccelerometer 20 that is preferably configured detect and monitoranatomical positions and physical movement of the subject, and generateand transmit accelerometer signals representing same, includingaccelerometer data representing at least one anatomical position of thesubject.

In this embodiment, the processing system of the electronics module 6 isalso programmed to determine a respiratory disorder as a function ofmeasured respiratory and physiological parameters, and accelerometerdata of the subject, and at least one anatomical position of the subjectas a function of the accelerometer data.

Referring now to FIG. 4 , there is shown an embodiment of a wearablegarment 220 that can incorporate a monitoring system of the invention,including monitoring systems 100 and 102 shown in FIGS. 1-3 .

As indicated above and illustrated in FIG. 4 , the wearable garment 220is preferably configured to cover at least the upper torso 210, i.e.,the thoracic and abdominal regions, of a subject 200.

According to the invention, the wearable garment 220 can, however, alsobe configured to cover other regions of the subject 200, including,without limitation, the lower abdominal region.

As illustrated in FIG. 5 , in a preferred embodiment, when the wearablegarment 220 incorporates a monitoring system of the invention (and,hence, forms a wearable monitoring system) and is positioned on theupper torso 210 of a subject, the transmitter coil 15 is preferablypositioned proximate the subject's xyphoid process and the firstreceiver coil 16 a is positioned proximate the umbilicus, the secondreceiver coil 16 b is positioned proximate the subject's spine oppositethe transmitter coil 15, and the third receiver coil 16 c is positionedproximate the subject's spine opposite the umbilicus.

According to the invention, when the noted wearable monitoring system ispositioned proximate the upper torso 210 of a subject 200 and themonitoring system is initiated, respiratory disorders and anatomicalpositions of the subject 200 can be accurately determined.

As will readily be appreciated by one having ordinary skill in the art,the present invention provides numerous advantages compared to prior artmethods and systems for determining respiratory characteristics andrespiratory disorders therefrom, and anatomical positions and movementof a subject.

Among the advantages are the following:

-   -   The provision of wearable physiological monitoring systems that        accurately detect and measure respiratory parameters and/or        characteristics in real time based on anatomical displacements        of a monitored subject.    -   The provision of wearable physiological monitoring systems that        that accurately determine anatomical positions of a subject.    -   The provision of wearable physiological monitoring systems that        train a subject to maintain an anatomical position during sleep        that is less likely to exacerbate and/or trigger a symptom of an        existing respiratory or sleep disorder of the subject.    -   The provision of improved methods for determining a respiratory        disorder based on detected respiratory and/or physiological        parameters and/or characteristics.    -   The provision of improved methods for determining sleep apnea        and/or hypopnea based on detected abnormal respiratory and/or        physiological parameters and/or characteristics.    -   The provision of methods for training a subject to maintain an        anatomical position during sleep that is less likely to        exacerbate and/or trigger a symptom of an existing respiratory        or sleep disorder of the subject.

Without departing from the spirit and scope of this invention, one ofordinary skill can make various changes and modifications to theinvention to adapt it to various usages and conditions. As such, thesechanges and modifications are properly, equitably, and intended to be,within the full range of equivalence of the following claims.

What is claimed is:
 1. A wearable physiological parameter monitoringsystem, comprising: a wearable garment that is configured to beremovably positioned on an upper torso of said subject, whereby saidwearable garment covers said upper torso of said subject, said uppertorso region of said subject comprising at least first and secondanatomical regions, said physiological monitoring system comprising apower source, respiratory parameter monitoring sub-system, aphysiological parameter sub-system, and an electronics module, saidpower source, respiratory parameter monitoring sub-system andphysiological parameter sub-system being in communication with saidelectronics module, said physiological parameter sub-system comprisingan accelerometer configured to detect anatomical positions and movementof said subject, and generate and transmit accelerometer signalsrepresenting same, said respiratory parameter monitoring sub-systemcomprising a transmitter coil and a receiver coil, said transmitter coiland receiver coil being positioned on said wearable garment, whereby,when said wearable garment is positioned on said subject, saidtransmitter coil is positioned proximate said first anatomical region ofsaid subject's upper torso and said receiver coil is positionedproximate said second anatomical region of said subject's upper torso inaxial alignment with said transmitter coil, said transmitter coil beingadapted to generate a plurality of alternating current (AC) magneticfields in a plurality of field dimensions, said plurality of fielddimensions comprising a plurality of field dimension frequencies, saidplurality of AC magnetic fields comprising a first AC magnetic fieldcomprising first, second and third field dimensions, said first, secondand third field dimensions of said first AC magnetic field comprising afirst field frequency of said plurality of field dimension frequencies,said first field dimension of said first AC magnetic field comprising afirst variable strength as a function of a first distance of saidreceiver coil from said transmitter coil, said second field dimension ofsaid first AC magnetic field comprising a second variable strength as afunction of a second distance of said receiver coil from saidtransmitter coil, and said third field dimension of said first ACmagnetic field dimension comprising a third variable strength as afunction of a third distance of said receiver coil from said transmittercoil, said receiver coil being configured to detect and measure saidfirst, second and third variable field strengths in said first, secondand third field dimensions of said first AC magnetic field, saidreceiver coil being further configured to generate a first AC magneticfield strength signal representing said first variable field strength insaid first field dimension of said first AC magnetic field, a second ACmagnetic field strength signal representing said second variable fieldstrength in said second field dimension of said first AC magnetic field,and a third AC magnetic field strength signal representing said thirdvariable field strength in said third field dimension of said first ACmagnetic field, and transmit said first, second and third AC magneticfield strength signals to said electronics module, said electronicsmodule being adapted to receive said first, second and third AC magneticfield strength signals transmitted by said receiver coil and saidaccelerometer signals transmitted by said accelerometer, saidelectronics module comprising a processing system that is programmed andconfigured to determine at least one respiratory parameter of saidsubject as a function of said first, second and third AC magnetic fieldstrength signals transmitted by said receiver coil and saidaccelerometer signals transmitted by said accelerometer, said processingsystem being further programmed and configured to determine a value ofsaid at least one respiratory parameter of said subject as a function ofsaid first, second and third AC magnetic field strength signalstransmitted by said receiver coil and said accelerometer signalstransmitted by said accelerometer, said processing system being furtherprogrammed and configured to determine at least one respiratory disorderof said subject as a function of said determined at least onerespiratory parameter and said determined value thereof.
 2. The systemof claim 1, wherein said electronics module is further programmed andconfigured to determine at least one anatomical position of said subjectas a function of said first, second and third AC magnetic field strengthsignals and said accelerometer signals.
 3. The system of claim 1,wherein said physiological parameter sub-system further comprises a SpO²sensor configured to detect and measure blood oxygen saturation levelsof said subject, and generate and transmit SpO² signals representingsame to said electronics module.
 4. The system of claim 3, wherein saidelectronics module is further programmed and configured to determinesaid at least one respiratory parameter and value thereof of saidsubject as a function of said first, second and third AC magnetic fieldstrength signals transmitted by said receiver coil, said accelerometersignals transmitted by said accelerometer and said SpO₂ signals, andsaid at least one respiratory disorder of said subject as a function ofsaid determined at least one respiratory parameter and said determinedvalue thereof.
 5. The system of claim 1, wherein said first anatomicalregion of said subject comprises a thoracic region of said subject andsaid second anatomical region comprises an abdominal region of saidsubject.
 6. The system of claim 1, wherein said electronics module isfurther programmed and configured to generate at least one respiratorydisorder warning signal that induces an excitation event when saiddetermined at least one respiratory parameter exceeds a predeterminedrespiratory parameter threshold.
 7. The system of claim 6, wherein saidat least one respiratory parameter comprises an apnea/hypopnea index(AHI) of said subject, and wherein said predetermined respiratoryparameter threshold comprises an AHI score in the range of 5-15 apneicevents per hour of said subject's sleep.
 8. The system of claim 6,wherein said at least one respiratory parameter comprises minuteventilation of said subject, and wherein said predetermined respiratoryparameter threshold comprises a reduction of said subject's minuteventilation of at least 30% of said subject's average normal minuteventilation.
 9. The monitoring system of claim 6, wherein said at leastone respiratory parameter comprises a breathing rate of said subject,and wherein said predetermined respiratory parameter threshold comprisescessation in said subject's breathing for at least 10 seconds.
 10. Thesystem of claim 1, wherein said at least one respiratory parameter ofsaid subject comprises an apnea.
 11. A method for determining arespiratory disorder of a subject, comprising the steps of: (i)providing a wearable physiological monitoring system that is configuredto be removably positioned on an upper torso of said subject, wherebysaid physiological monitoring system covers said upper torso of saidsubject, said upper torso region of said subject comprising at leastfirst and second anatomical regions, said physiological monitoringsystem comprising a power source, respiratory parameter monitoringsub-system, a physiological parameter sub-system, and an electronicsmodule, said power source, respiratory parameter monitoring sub-systemand physiological parameter sub-system being in communication with saidelectronics module, said physiological parameter sub-system comprisingan accelerometer configured to detect anatomical positions and movementof said subject, and generate and transmit accelerometer signalsrepresenting same, said respiratory parameter monitoring sub-systemcomprising a transmitter coil and a receiver coil, said transmitter coiland receiver coil being positioned on said wearable garment, whereby,when said wearable garment is positioned on said subject, saidtransmitter coil is positioned proximate said first anatomical region ofsaid subject's upper torso and said receiver coil is positionedproximate said second anatomical region of said subject's upper torso inaxial alignment with said transmitter coil, said transmitter coil beingadapted to generate a plurality of alternating current (AC) magneticfields in a plurality of field dimensions, said plurality of fielddimensions comprising a plurality of field dimension frequencies, saidplurality of AC magnetic fields comprising a first AC magnetic fieldcomprising first, second and third field dimensions, said first, secondand third field dimensions of said first AC magnetic field comprising afirst field frequency of said plurality of field dimension frequencies,said first field dimension of said first AC magnetic field comprising afirst variable strength as a function of a first distance of saidreceiver coil from said transmitter coil, said second field dimension ofsaid first AC magnetic field comprising a second variable strength as afunction of a second distance of said receiver coil from saidtransmitter coil, and said third field dimension of said first ACmagnetic field dimension comprising a third variable strength as afunction of a third distance of said receiver coil from said transmittercoil, said receiver coil being configured to detect and measure saidfirst, second and third variable field strengths in said first, secondand third field dimensions of said first AC magnetic field, saidreceiver coil being further configured to generate a first AC magneticfield strength signal representing said first variable field strength insaid first field dimension of said first AC magnetic field, a second ACmagnetic field strength signal representing said second variable fieldstrength in said second field dimension of said first AC magnetic field,and a third AC magnetic field strength signal representing said thirdvariable field strength in said third field dimension of said first ACmagnetic field, and transmit said first, second and third AC magneticfield strength signals to said electronics module, said electronicsmodule being adapted to receive said first, second and third AC magneticfield strength signals transmitted by said receiver coil and saidaccelerometer signals transmitted by said accelerometer, saidelectronics module comprising a processing system that is programmed andconfigured to determine at least one respiratory parameter of saidsubject as a function of said first, second and third AC magnetic fieldstrength signals transmitted by said receiver coil and saidaccelerometer signals transmitted by said accelerometer, said processingsystem being further programmed and configured to determine a value ofsaid at least one respiratory parameter of said subject as a function ofsaid first, second and third AC magnetic field strength signalstransmitted by said receiver coil and said accelerometer signalstransmitted by said accelerometer, said processing system being furtherprogrammed and configured to determine at least one respiratory disorderof said subject as a function of said determined at least onerespiratory parameter and said determined value thereof, (ii)positioning said monitoring system on a first subject; (iii) initiatingsaid monitoring system via said power source, wherein said first ACmagnetic field is generated and transmitted by said transmitter coil;(iv) detecting and measuring said first, second and third variable fieldstrengths in said first, second and third field dimensions of said firstAC magnetic field with said receiver coil; (v) generating said first,second and third AC magnetic field strength signals with said receivercoil; (vi) measuring accelerometer data with said accelerometer andgenerating said accelerometer signals representing said accelerometerdata; (vii) transmitting said first, second and third AC magnetic fieldstrength signals to said electronics module with said first receivercoil; (viii) transmitting said accelerometer signals to said electronicsmodule with said accelerometer; (ix) determining at least onerespiratory parameter and value thereof of said first subject as afunction of said first, second and third AC magnetic field strengthsignals and said accelerometer signals with said electronics module; and(x) determining at least one respiratory disorder of said first subjectas a function of said determined at least one respiratory parameter andsaid determined value thereof with said electronics module.
 12. Themethod of claim 11, wherein said electronics module is furtherprogrammed and configured to determine at least one anatomical positionof said subject as a function of said first, second and third ACmagnetic field strength signals and said accelerometer signals.
 13. Themethod of claim 12, wherein the method further comprises the step ofdetermining at least a first anatomical position of said subject as afunction of said first, second and third AC magnetic field strengthsignals and said accelerometer signals.
 14. The method of claim 11,wherein said physiological parameter sub-system further comprises a SpO²sensor configured to detect and measure blood oxygen saturation levelsof said subject, and generate and transmit SpO² signals representingsame.
 15. The method of claim 14, wherein said electronics module isfurther programmed and configured to determine said at least onerespiratory parameter and value thereof of said subject as a function ofsaid first, second and third AC magnetic field strength signalstransmitted by said receiver coil, said accelerometer signalstransmitted by said accelerometer and said SpO² signals, and said atleast one respiratory disorder of said subject as a function of saiddetermined at least one respiratory parameter and said determined valuethereof.
 16. The method of claim 15, wherein the method furthercomprises the steps of detecting and measuring at least a first bloodoxygen saturation level of said subject with said SpO² sensor,generating and transmitting at least a first SpO² signal representingsaid at least a first blood oxygen saturation level of said subject tosaid electronics module with said SpO² sensor, determining said at leastone respiratory parameter and value thereof of said subject as afunction of said first, second and third AC magnetic field strengthsignals transmitted by said receiver coil, said accelerometer signalstransmitted by said accelerometer and said SpO² signals, and determiningsaid at least one respiratory disorder of said subject as a function ofsaid determined at least one respiratory parameter and said determinedvalue thereof.
 17. The method of claim 11, wherein said first anatomicalregion of said subject comprises a thoracic region of said subject andsaid second anatomical region comprises an abdominal region of saidsubject.
 18. The method of claim 11, wherein said at least onerespiratory parameter of said subject comprises an apnea.